Whether driven by regulatory, reimbursement, policy, or investment tailwinds, 2026 is poised to be a pivotal year for healthcare innovation leveraging artificial intelligence and machine learning (AI/ML). Countless AI/ML HealthTech innovations assist, augment, and in some cases automate clinical decisions, diagnoses, and operational workflows— and a meaningful portion of these tools remains outside formal FDA premarket authorization, either because they fall outside the statutory definition of a medical device or because FDA has exercised risk-based enforcement discretion. In early January, FDA released updated guidance that further clarified how the agency intends to apply these boundaries in practice, including circumstances in which certain AI-enabled tools may be commercialized without premarket authorization.
This whitepaper examines why, despite this increasing regulatory flexibility for certain AI applications, pursuing FDA authorization and product-specific coding, coverage, and reimbursement can remain a highly attractive commercial path—and in some use cases, the most durable route to long-term scale.